100. The Data Protection Act incorporates into UK
law the European Directive of 1995 (Directive 95/46/EC) on the
protection of individuals with regard to the processing of personal
data. It provides important safeguards for individuals about whom
data are stored, including a requirement that they consent to
storage and processing of personal data about them. Exemptions
to this provision include certain uses of data for statistics
and research purposes, but these are less precisely defined in
the UK legislation than in the European Directive, which exempts
data "required for the purposes of preventive medicine, medical
diagnosis, the provision of care or treatment or the management
of health-care services, and where those data are processed by
a health professional subject under national law or rules established
by national competent bodies to the obligation of professional
secrecy or by another person also subject to an equivalent obligation
of secrecy".[146]

101. Local interpretations of the Data Protection
Act have already led to anomalies in cancer registration practice.
The UK Association of Cancer Registries told us that some hospitals
are requesting that the service level agreements being established
with cancer registries include a clause requiring patients' consent
for inclusion of their data.[147]
The Institute of Cancer Research told us that enforcement of the
1998 Act has already seriously held up their research into mesothelioma.
Whereas previously, medical and other patient records were available
to bona fide medical researchers, access now appears to
require explicit patient permission in each case.[148]
The London School of Hygiene and Tropical Medicine believes that
if this interpretation of the Act is correct then "it would
make both cancer registration and almost all cancer epidemiological
research effectively impossible".[149]
Professor Ponder is concerned that this could "destroy the
cancer registration system".[150]
He reports having received advice from a MREC that "in effect,
all of the genetic epidemiology studies which form a large part
of our work, are in their opinion illegal... because of doubts
whether cancer registration itself is legal".[151]

102. We agree that access to high quality data on
incidence and outcome of cancer is an essential tool in the study
of cancer and that it would be a great loss if implementation
of the Data Protection Act 1998 were to compromise the integrity
and comprehensiveness of these data or hinder researchers' access
to them. We believe that a requirement for informed consent for
cancer registration would be difficult to administer and costly,
and would almost certainly lead to unquantifiable selection bias,
making the data far less useful. In some circumstances, for example
the investigation of childhood leukaemia in the vicinity of nuclear
installations, it might become difficult to retain any confidence
in the data.

104. One solution put to us to ensure that cancer
registries can continue to collect comprehensive data and analyse
them, and that registry data remain available to bona fide
researchers, is to make cancer a notifiable disease.[154]
The London School of Hygiene and Tropical Medicine told us that
making cancer notifiable would have three benefits: it would emphasise
the political importance attached to cancer; registration would
become exempt from the 1998 Act requirement for patient consent;
and it would place a legal obligation on NHS Trusts and laboratories
to co-operate in registration, thus improving the quality of public
health data on cancer available to Government and researchers.[155]

105. The Data Protection Commissioner would appear
to agree. Ian Bourne, the Compliance Manager (Health) in the Commissioner's
Office, told us that "cancer registration could be put on
a statutory basis, as is the case with notifiable diseases. This
means that practitioners must or could disclose regardless of
the wishes of the individual data subjects. Although it is not
for the Commissioner to take a view as to whether cancer registration
should be put on a statutory basis, by virtue of [Section] 35
of the 1998 Act personal data are exempt from the non-disclosure
provisions where the disclosure is required by or under any enactment
or by any rule of law.".[156]

106. Legislative or regulatory measures for compulsory
cancer registration are in force in almost half the 50 countries
reporting data to the World Health Organisation's international
compendium of cancer statistics.[157]
In the USA, the Cancer Registries Amendment Act 1992 invoked a
National Program of Cancer Registries, noting that statewide cancer
incidence and mortality data can be used to examine the ethnic
and geographical variations and to direct cancer control interventions.[158]
The Act enables the US Health Secretary "to support the operation
of population-based statewide cancer registries to collect, for
each form of in-situ and invasive cancer (with the exception of
basal cell and squamous cell carcinoma of the skin)",
demographic, occupational and administrative data on each
person with cancer and the data of the diagnosis, pathology and
treatment of cancer.

107. When we asked the Minister if she had considered
the option of making cancer notifiable she told us that this was
"not a proposal which I have looked at before" and that
there was "potential for cancer registries to make a big
difference without needing to do that".[159]
The National Cancer Director suggested that this issue should
be "revisited if we had problems actually getting 100 per
cent information or near 100 per cent information on cancer patients".[160]
The Chief Medical Officer for England, Dr Liam Donaldson, has
previously described the national cancer registry as "the
best example of a disease register that attempts to provide comprehensive,
routinely available data for the whole of Britain on an important
group of diseases".[161]
A recent British Medical Journal editorial on cancer trends in
England and Wales points out that "Tough but achievable targets
cannot be set, services planned, and performance audited without
high quality, timely, and complete statistics on incidence, mortality
and survival by tumour type; analysis of their trends and of the
factors explaining these trends; and predictions of the effects
of these factors as the age structure of the population changes.
This is an enormous but under-funded task: it currently takes
six years to report the number of cancers which occur in a specific
year.".[162]
The cancer registries covering Great Britain have been in operation
for 40 years and comprise the largest national collection of such
data in the world; they have been the source of a very large volume
of research on the causes, prevention and treatment of cancer
and survival from cancer.

108. We believe that this is not an area where there
is any room for complacency. Operation of the cancer registry
in Saarland, Germany, was suspended for more than a year due to
enactment of a federal data protection law in 1977. On reopening
in 1979 access to data for research was still restricted. The
former East German cancer registry, in operation since 1953, was
forced to close under the same law after the re-unification with
West Germany in 1991.[163]
Accurate and comprehensive data sets on cancer incidence and outcome
are crucial for public health research into the causes and effective
treatment of cancer. Some research projects are already under
threat, even where there is no threat to patient confidentiality.[164]

109. We note that an advisory group has been established
to examine the issue of patient confidentiality and data protection
across the NHS. We recommend that, as a matter of urgency,
the advisory group on patient confidentiality should address the
concerns posed by the 1998 Data Protection Act regarding the registration
of cancer.

110. Making cancer a notifiable disease would be
a departure from the established practice of applying notification
solely to infectious diseases. Some cancers may be caused by the
long-term effects of persistent viral infections (for example,
liver cancer and hepatitis B), but we feel there is a risk that
allowing cancer to become associated with infectious notifiable
diseases by using the same legal mechanisms to ensure its registration
could give rise to the unwelcome impression that cancer patients
should be isolated. Making the registration of cancer a legal
requirement through separate legislation would, however, ensure
that cancer registries have comprehensive and useful data. Accessing
those data for research purposes would continue to require approval
from a research ethics committee (REC) and patient confidentiality
issues could, as now, be dealt with at that stage. Ethics committees
properly require that patient records are only used for worthwhile
research purposes and we accept that they represent a rigorous
safeguard.[165]

111. One concern about patient confidentiality is
that in some research it is necessary for researchers to approach
patients for whom a cancer diagnosis has been recorded in the
register. This is usually done through the patient's GP who advises
whether or not such an approach would cause distress to the patient.[166]
Such safeguards can be and already are routinely imposed by ethics
committees in order to protect patients' interests without unnecessarily
obstructing important research.

112. We recommend that the Government should introduce
legislation to make the registration of cancer a legal requirement,
both to ensure the completeness of cancer registry data and to
ensure access to those data for legitimate research purposes.

114. Like the rest of the NHS, cancer registries
have collected ethnicity data since 1993 and, over time, better
quality data should become available on which to base further
investigations into links between race or ethnic group and cancer.
It is important to understand such links since they affect the
way in which cancers should be treated and the way in which public
health education is best delivered. We would welcome initiatives
to extend research on the links between ethnicity, socio-economic
conditions and cancer incidence and survival.

117. Palliative care seeks to ease the impact of
living with cancer and its treatment. Patients' quality of life
when receiving toxic drugs or when in the untreatable stages of
cancer can be greatly improved with good palliative care.[176]
Macmillan Cancer Relief argued that "this is particularly
true of vulnerable patients in an advanced stage of the disease
for whom invasive treatment may be inappropriate".[177]
Nevertheless, research into service development and patient care
is accorded far less priority for funding and attracts far less
academic interest. Macmillan Cancer Relief, which told us of the
positive results of its research into the benefits of care-based
research on patient outcomes, appears to be one of the few organisations
investing in research in this area.[178]
The Royal Pharmaceutical Society told us that research priorities
may be distorted because "there are no clear national targets
relating to this area of opportunity, and the health economic
and other evaluative techniques currently in use may not attribute
an appropriate value to care which is not life extending".[179]
We recommend that palliative care research should be conducted
as a complement to research into cancer treatments and should
receive Government funding.

119. Scientific judgements on the timeliness, feasibility
and promise of various research approaches are matters properly
left to experts. We have been persuaded, however, that decisions
over long-term strategies for tackling cancer can and should involve
patients, carers and their representatives. In some instances
this already happens. Some research committees have patients representatives.
Indeed, one of our witnesses, Gillian Speed, a cancer patient
from Sheffield, is a patient representative on the North Trent
Cancer Network Culyer Funding Team.[184]
Research Ethics Committees also have lay members. Patients should
also be consulted in the design and delivery of clinical trials.
Moreover, as Cancerlink told us, patient involvement of this kind
requires investment in training and support to build the capacity
of patients and their representatives to take part in the research
decision-making process.[185]
We recommend that all Government-supported cancer research
committees include patients' representatives as full members and
that the Government provides resources to ensure proper training
and support for patients' representatives.